Process-linked data management system

ABSTRACT

A system for managing and reporting laboratory data wherein the data is obtained at remote data-taking stations, transferred instantaneously by wireless communication to a main data-storing/manipulating station for recording therein without being recorded at the remote data-taking stations, and reported only from the data-storing/manipulating.

FIELD OF THE INVENTION

The present invention relates to systems and methods for managing data.More specifically, it relates to systems for inputting, tracking,recording and reporting laboratory data and information such as testprocedures, measurements, test results, and test reports, especiallyduring the development, pre-market evaluation and production of chemicaland pharmaceutical products.

BACKGROUND OF THE INVENTION

During the development and production of many pharmaceutical andchemical products it is necessary to perform various tests andevaluations and maintain various records, then to manipulate the resultsof these tests and evaluations and prepare various reports thatinterpret and summarize those results. Such activities are generallyperformed in accordance with a set of laws and guidelines provided bythe agency, such as the FDA, which controls or approves themarket-release of the products and Standard Operating Procedures(SOP's), prepared by the manufacturer's internal Quality Assurancedepartment (QA), or by an independently contracted auditor.

It is estimated that in the pharmaceutical laboratory 70% or morelaboratory staff time is spent on documentation related to these tests,not actual laboratory operations. Cycle times from sample arrival tocertificate of analysis are often quoted at 10 to 15 days. The QC/QAreview cycle often challenges the data or the analysis, generatinginvestigations to support the conclusions. Out of spec or out of trendresults discovered during review are well beyond the time of theoperation that generated them. To reduce cycle time in the laboratory,it is imperative to present error free, valid measurements.

Several computer-based data management systems specifically intended foruse in such analytical laboratories have been designed over the yearsand are known generically as Laboratory Information Management Systems(LIMS). LIMS systems and chromatography data systems are common systemsin pharmaceutical labs. While these systems often archive the analyticalresults, and provide reports, they are usually oriented too late in theprocess to insure original data integrity.

The inventors believe that a critical need exists to capture, validateand secure laboratory data as close to the source as possible.Technology needs to be developed which will perform this function withsimple equipment and clear interfaces for laboratory personnel andinstruments.

Under present procedures, authorized analysts are provided with SOP'sand, using properly calibrated instrumentation, perform theaforementioned tests and manually record the aforementioned data inaccordance therewith. Once all data has been collected, it istranscribed into a batch record within a computer for interpretation andmanipulation, and thereafter, for compilation into such reports as mightbe dictated by the SOP. The agency, auditor, or QA inspector can viewthe report(s), while simultaneously viewing the SOP and the supportingdata to interpret the report and judge both its validity and itsacceptability.

The approval and certification agencies for pharmaceutical products andmany chemical products, such as the FDA, generally require theperformance of such tests and evaluations and the production of suchreports in conjunction with both development and production. Performanceof these tests, access to the resulting data, and ability to manipulateit must be strictly limited to only authorized individuals. Theserequirements result in a tremendous physical and logistical problem, asthe evaluation periods can be lengthy and huge quantities of data oftenaccrue. Since present methods fail to recognize many anomalies in theserequirements until the report-writing phase, that being the final phasein the process, tremendous delays and expense result when such anomaliesprove results erroneous or invalid, polluting the batch record andcausing the need for extensive re-testing so late in the process.

LIMS systems of some sort have always been essential tools in suchresearch and development labs, in-process testing labs, and qualityassurance labs as are involved in such testing and reporting. Typically,a LIMS is a software program loaded into the computer that receives thedata collected from the instruments, either electronically or manually,manipulates and interprets it, maintains it, and presents it forindependent inclusion in the required report(s). This information canthus be sorted and organized within the batch record or externally intovarious report formats based upon the type of report required.

As recently as the nineteen-seventies, laboratory notebooks andhandwritten notes were the preferred tools used to track and recordinformation. Thereafter, although handwritten notebooks are still in usetoday for certain data, custom-designed LIMS were configured byindividual laboratories to allow certain analytical instruments tocommunicate directly with the main server. Such “in-house” systems,which are still being used to this day by many labs, can takeconsiderable time and cost to develop, can require considerableresources and attention to maintain, yet still require many manual stepsand documentation stages in order to satisfy most approval andcertification requirements.

Even with the use of a LIMS, once data has been collected, it must firstbe downloaded, either manually or electronically, into the LIMS' batchrecord file. Each such recordation thus created presents an additionalneed for preservation and additional point of possible transcriptionerror. Additionally, the recording of such data, which is generallyproprietary, in and from numerous locations, increases the potential foraccess to this data by unauthorized individuals and presents a serioussecurity concern.

Generally, data is either recorded manually or stored within a datacollection system associated with the collecting instrumentation itself.For example, if an electronic scale is used, the weight data collectedwill normally be stored in a memory within that scale. Although thisdata can be transferred electronically to the server to minimize error,the need to maintain and report details about that original record isnot eliminated.

Since the introduction of customized LIMS, great strides have been madein the electronic interfacing of instrumentation and data manipulatingequipment. These have made feasible and provided an incentive for thedevelopment of a truly universal system to connect all instrumentationwith both the server and the SOP's to thereby integrate all data,procedures, and results into one cohesive batch record which can produceone cohesive and inclusive report. This further provides an opportunityto reduce the record-keeping burden by minimizing record maintenancerequirements, to improve security, and to expedite the evaluationprocess. Further, the cumbersome need to manually compare and interprettest results against the SOP can be eliminated and the discovery ofinvalidities and discrepancies prior to the final stage of the processcan be realized.

By linking the testing, the recordation and manipulation of resultingdata, and the generation of reports directly with the process itself, asprovided by the present invention, it becomes possible to greatlystreamline and expedite the approval process.

OBJECTS OF THE INVENTION

It is an object of the present invention to provide a laboratory datamanagement system in which SOP's are linked directly with the computerand instrumentation to provide a report that integrates all proceduralinformation, supporting data, test interpretation, and test validityconfirmation.

It is an object of the present invention to provide a laboratory datamanagement system in which data maintenance requirements are minimizedand simplified.

It is an object of the present invention to provide a laboratory datamanagement system in which the dependence on hand written and paperrecords is eliminated.

It is a further object of the present invention to provide such a systemin which the likelihood of a transcription error is eliminated.

It is a further object to provide a system in which security is improvedthrough the elimination of many written records and in which theunauthorized access to data records can be significantly reduced.

It is a further object to provide a system that is more universallyadaptable to a variety of laboratory environments.

It is still a further object to provide a data management system thatverifies that procedures are being properly followed on a real-timebasis to ensure that errors are recognized immediately.

It is still a further object to provide a data management system thatverifies that operators are qualified to perform tests and accessinformation on a real-time basis.

It is still a further object to provide a data management system thatverifies that results are within desired ranges on a real-time basis toensure that variations are recognized immediately.

It is a further object to provide a data management system that verifiesthat equipment is properly calibrated on a real-time basis to ensurethat variations are recognized immediately.

Further objects and advantages of the present invention will be bestappreciated and more fully understood in reference to theherein-described preferred embodiment and the appended drawings.

SUMMARY OF THE INVENTION

The present invention is a universally adaptable Process-Linked Datasystem (PLD) for managing and reporting laboratory data wherein theprocedures of the SOP itself are used to manage the performance oftests, to receive and record the resulting data, and to generate therequired reports.

A unified data acquisition system is provided to simplify the laboratoryenvironment. Since collecting data in conformance with the latestfederal regulations (21CFR Part 11) requires that the data sources beidentified, that the data be put into a secure repository and thataccess be restricted to authorized personnel, the present PLD RecordStorage system will provide a compliant repository for electronicrecords in the laboratory.

The PLD Procedure Execution and Management system provides for primarydata capture as an integral part of executing standard test proceduresin the laboratory. Only authorized personnel may perform transactionsthat add, change, or affect data in any way. Means of identifying thepersons performing the transactions is required.

Grouped identifiers are not allowed by FDA regulations. Sinceconventions for user ID's and passwords vary from one company toanother, a customer SOP must be prepared to specify user name andpassword practices. The present PLD system has settings to allowenforcement of the uniqueness, frequency of change and re-userequirements specified in the SOP. When biometric identification ofindividuals is used, the system can also ensure that unique individualsare identified.

Terminal “sessions” must be established during which an identifiedindividual is making data entries or controlling the collection of datafrom instruments. The terminal device may not be left unattended whilethe session is active. If the operator leaves the terminal device,she/he must close the session to prevent unauthorized entries. It iscommon to have an automated data collection activity that was startedduring a valid session continue after the session is closed. Anotherneed is to enable a different individual (either to take over in casethe original person is no longer available, or to act with higherauthority) to initiate a terminal session and interact with ongoing datacollection. The new individual must be properly identified and all datatagged with his identity.

The access control records of PLD are themselves stored in the PLD database. The system allows for biometric identification of people andcreates terminal sessions. Operators are able to log out. A reminder isdisplayed to attend the terminal at all times until log out. Terminalsessions may be resumed by any authorized person. All data collected istagged with the operators identity.

The PLD Access Control System includes an enumeration of individualstogether with the list of authorized activities and the list ofauthorized values for various security attributes. The access controlsystem compares the security attributes of both the record and theindividual to find a match before access to the record is granted. Thesystem will only accept transactions from authorized individuals.Eligibility is based on user training on specific procedures. Access totraining records is needed to determine eligibility. Enforcement by thesystem is an installation configuration switch. Supervisor approval isneeded for non-eligible personnel to perform procedures.

21CFR Part 11 does not mandate electronic signatures, but without themassociated paper documents must be produced, linked and signed. Thepresent system supports a fully “paperless” system. An electronicsignatures is an integral part of the present system.

An audit trail for each data field is maintained containing the entiredata history. All changes are identified with the information includingwho performed the change (by entering the password or signature) andwhen was the change performed. A record of the data before the changewas performed is kept. The reason for changes to the data are recorded.

Audit trail records must never be changed. They must containunquestionable ties to the live data. No “rollback” facilities areavailable. The audit trail will grow over time and must be supported byhardware and software that introduces minimal delays in transactionprocessing.

There are three identification components: the operator, the equipmentand the sample. This system will positively identify each of these.

Once the SOP is loaded into the PLD, a Method Instruction set (MI) iscreated which defines the test parameters and materials needed, preparesinstructions for the instrumentation and test personnel, opens a batchrecord file, sets up a report outline, and follows the performance ofeach activity through to either a failure or successful conclusion. Thesystem is equipped to either prompt the personnel to input each andevery piece of information needed or obtain that data directly, and thesystem is equipped to either halt the process or alert the user whenevera specification is not met, an invalid test parameter is encountered, orerroneous or missing data is sensed, to avoid the possibility of havingsuch discrepancies go unrecognized until later in the process or topropagate into other areas of the system.

This system even accepts data from Electronic Clipboard devices formanual input where an observation is made by lab personnel or wherethere is no means other than transcription to capture instrumentreadings.

The clipboard may be coupled to a vision device that can read barcodeand alphanumeric displays, converting these displays into text. Theclipboard device will also support infra red and wireless LANcommunication to the data server.

A Secure Shell for PC based legacy instruments inserts itself at theapplication/operating system interface. It behaves mostly like a devicedriver for disk storage and/or printer devices. To the application itprovides the entire Application Programming Interface (API) currentlyused by the application. Additional functionality is provided by dialogand data storage that is external to the legacy application. The dialogsacquire all additional information needed, maintain audit history, andprevent record corruption.

Data may be taken electronically from an instrument when the sample isprocessed. In this case the data is transmitted directly to the securerepository. Data may also be acquired from instruments operated bynetworked computers. The resulting analysis record filed on thenetworked computer is accessed and extracted data is transmitteddirectly to the secure repository. The detailed report of analysis isrecorded in the repository also to support the extracted data. TheElectronic Clipboard is used as the user terminal for control of thedata transfer.

The instrument interfacing can be performed by personnel who understandthe communication interface description of the instrument. An interfacegenerator is used to generate interface descriptions that will be run inthe server. Conventional programming is not required. A process forinstalling interface instructions into the system is available. Therepository is physically and logically secured. The readings andassociated ID's are immutable. The identity of the operator is verifiedwhen a terminal session is begun. The operator training records and theequipment calibration records are accessed before measurements are takento alert the operator. A specific override is required by the operatorto continue. The storage of the data includes means to capture orconstruct the state of operator training and equipment certification atthe time of measurement.

An optional means for storing the expected value or range of values formeasurements is provided. When expected values are specified, the dataentering storage is compared to the expected values. An alert isprovided to the operator when the measurement differs from expectedvalues.

Devices for sample, operator and equipment ID capture are easy to useand require minimal change to present laboratory procedures. The dataentry devices are primarily menu and select list oriented. Pen based andtouch screen techniques are preferred.

In order to collect primary data at the source, either a wiredconnection or a local data terminal is available. This system will havea personal terminal. The personal terminal is easy to carry and to enterdata on, can be set on the lab bench and used there or in the hands, hasan operation time of at least 4 hours before routine service (such asbattery charging or changing) must be performed. The terminals arerecharged when not in use. In normal use, no cords are connected to theterminal. An optional use will connect the terminal to the network by adata cable. The system has either no connecting wires, or quicklyplugable wires to small connection ports with high life connectors. Thesystem displays the same dialogues from the system that are displayed onconventional PC devices. The system is able to provide positiveidentification of the device used. The system is able to scan bar codesfor identification of samples, reagents, instruments, etc. Ethernet andTCP/IP are the preferred communication among devices connected by wires.IrDA standards are applied to devices that may communicate by infraredbeams.

Once the data is obtained at remote data taking stations such as theaforementioned analytical instrumentation, it is transferredinstantaneously to the main server for recording only in the batchrecord file, without being recorded at the remote data taking stations,to eliminate the need for record maintenance and auditing at thoseremote devices. Users are identified, and their authorizations andcertifications are it, evaluated immediately. The functions that theycan perform and the records that they can access are controlled by thePLD system. Equipment specifications and calibrations are confirmedimmediately, and both raw and manipulated data are and need only berecorded in and reported from the batch record file. The resultingreport integrates the test results directly with the procedure toprovide a singular document which can be read and understood without theneed to maintain and refer to other documentation such as notebooks,calibration records, user qualification certificates, instrumentationrecords and computer files.

Structured Query Language (SQL) standards are used for data access and aSQL database product is used under the present system.

Since each reading, observation or other report is called for by aspecific prompt from the pre-approved procedures, and it is collectedand stored in a tightly coupled fashion to that part of the procedurerecord for each sample, record maintenance is greatly reduced whilesecurity is greatly increased. The processing needed to interpret andmove the data out of the instrumentation and into the batch record isdone at the time the data is collected, not later when the report isprepared.

The distinct advantage of this approach will be apparent wheninformation is being reviewed for compliance or other reasons later.Since the data is stored with the procedure and can be readilydisplayed, the original systems do not need to be consulted orpreserved. The main advantage of this system becomes apparent when weconsider the security and authentication requirements of the federallaws. By moving the data to a common procedure storage system,preferably without invoking any storage in the data collection system,all the record keeping requirements can be fulfilled in one systemrather than many.

In the past, access control or security features of computer systemsidentified individuals and enumerated the functions that those personswere allowed to perform. Some examples of these functions might be;edit, operate, create procedures, administrate, etc. The data thatresults from these operations are usually stored in a file system ordatabase, and complete security is obtained by only allowing thedesignated programs to operate on the data.

The present invention provides a system where individuals are identifiedand the record categories that they can manipulate are enumerated. Arecord storage system enforces the required authority for an individualto manipulate records, regardless of the processing system being used.This means that any record being retrieved is tested against the readauthority of the individual. Likewise updates and creation of newrecords require that authority in the individual.

Finally, the audit trail required by federal law is built into the datastorage system instead of the data processing system, as is the case inprior art systems. Since records must be stored for the duration of adefined record retention period, all activities performed on theserecords must also be recorded. Many different processing systems maycome into being over this long duration, and it may be desirable to usenot-as-yet-developed tools and equipment. There is a great advantage tohaving the audit trail generated and maintained by the storage system,without the need for special processing in every program.

Further advantages of the present invention will be best appreciated andmore fully understood in reference to the herein described preferredembodiment and the appended drawings, of which the following is a briefdescription.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic block diagram depicting the hardware of thepreferred system and interfacing therebetween,

FIG. 2 is a flow chart depicting the flow of data in a system accordingto the preferred embodiment of the invention,

FIG. 3 is a schematic representation of the preferred system'sthree-tier architecture,

FIG. 4 is a reproduction of the basic User Interface screen of thepreferred embodiment,

FIG. 5 is a reproduction of the Registered Procedure display screen ofthe preferred embodiment,

FIG. 6 is a reproduction of the Procedure Sessions screen of thepreferred embodiment,

FIG. 7 is a reproduction of the Approved Procedures screen of thepreferred embodiment,

FIG. 8 is a reproduction of the PLD Data screen of the preferredembodiment,

FIG. 9 is a reproduction of the Data Collection screen of the preferredembodiment,

FIG. 9A is a reproduction of Pop-Up Menu Selection screen of thepreferred embodiment,

FIG. 10 is a reproduction of the Data Review screen of the preferredembodiment,

FIG. 11 is a reproduction of the Network Instrument Data Entry screen ofthe preferred embodiment,

FIG. 12 is a reproduction of the Audit Trail Pop-Up screen of thepreferred embodiment,

FIG. 13 is a reproduction of the New Procedure Session screen of thepreferred embodiment,

FIG. 14 is a reproduction of the Rich Filter screen of the preferredembodiment,

FIG. 15 is a reproduction of several data collection boxes of thepreferred embodiment,

FIG. 15A a reproduction of the Reason Code Dialogue Box of the preferredembodiment,

FIG. 16 is a reproduction of the List of Registered Instruments toscreen of the preferred embodiment,

FIG. 17 is a reproduction of the Device Registration screen of thepreferred embodiment,

FIG. 18 is a reproduction of the Instrument Physical Output Connectionscreen of the preferred embodiment,

FIG. 19 is a reproduction of the Command Name screen of the preferredembodiment,

FIG. 20 is a reproduction of the Parsing Specification screen of thepreferred embodiment,

FIG. 21 is a reproduction of the Instrument Setup screen of thepreferred embodiment,

FIG. 22 is a reproduction of the Login Dialogue screen of the preferredembodiment,

FIG. 23 is a reproduction of the Registered Users screen of thepreferred embodiment, and

FIG. 24 is a reproduction of a Report Listing of the preferredembodiment.

DEFINITIONS

In order to best understand the following description, reference tothese definitions should be made;

Application Server: A computer system which can access programs andrecords contained in the records management system, execute thoseprograms and update records in the records management system.

Authentication: The process of checking the privileges of the identifiedindividual who is causing records to be created or updated. This processuses an authentication data base that contains individuals names andunique privilege identification means that are compared to the securityattributes of the records being created or updated. Authentication maynever be over ridden or ignored.

Control Sheet: A simple report usually associated with a standard testmethod, or series of methods. The paper control sheet is filled out bythe analyst(s) during performing the procedure(s). It contains all thefinal data required for product release or stability testing.

Electronic Clipboard: A device that is convenient to carry around in thelab. This device will display the output of the procedure interpreterand serve as a data collection and control device.

Eligibility: The process of determining the ability of an individual tocreate and modify records. The eligibility may be due to position,training, experience, delegation, or other reasons. It is most commonlya function of training. Eligibility may be over ridden or ignored insome situations.

Forwarding: Automatic actions based on PLD language specifications in aprocedure that create a transaction file for another software system toread as input.

Identification: The process of determining the identity of the personusing the system. This is accomplished by a combination of identifyingstring or token and password or biometric property.

Instrument Interface Device: A device that can connect to a laboratoryinstrument and to the bench-top network. The instrument interface willperform all control and protocol conversions required for acquisition ofdata from the instrument. No records may be stored in this device.

Parsing Specification: A description of an instrument data transactionused by the parsing function to extract a subset of information from thecomplete data stream. It includes descriptions of the triggers needed tocause the instrument output.

Procedure Interpreter: A software module that reads the procedure,identifies instructions intended for the data acquisition system, andcarries out those instructions. The procedure interpreter is stored inthe records management system and executes on the application server.

Procedure Session: A period of time relative to a standard procedure forspecific items during which the procedure is applied to those items.There are usually three phases to the Procedure Session: the preparationand performance phase; the review phase; and the approval phase. TheProcedure Session is available to only one authorized Terminal Sessionat a time.

Records Management System: A data base application which storescollected records and enforces record management disciplines on thoserecords including all the requirements of 21CFR Part 11. These recordmanagement disciplines include the collection of meta-data identifyingthe sources and individuals responsible for the records, as well as acomplete audit trail of all changes to the records.

Smart Shell: A computer program driver that mimics a disk device in theWindows operating system. Legacy applications may use this device as ifit were a traditional disk drive. The driver will recognize datapatterns as new storage or updates to existing storage. It will generatea dialogue in the Windows system to collect any required meta-data tofulfill record storage requirements. The smart shell will cause allinformation to be stored in the record management system.

Terminal Session: A period of time, relative to a particular terminaldevice, during which a known individual is interacting with thatterminal device. A policy that requires personal attendance by thatindividual to the device as long as the terminal session is active mustbe enforced. The individual must “log out” or otherwise end the terminalsession prior to leaving the device unattended.

Transaction File: A sequential file on a networked computer that isoutput by a software system for use by a second different softwaresystem. The second system reads the file and in doing so completes atransfer of data from the first system to the second system.

PLD Language Specification: Delimited statements contained in testprocedures that describe the format, source and destination of data.These statements are interpreted by the PLD language interpreter toperform data collection and record keeping operations.

DESCRIPTION OF THE PREFERRED EMBODIMENT OF THE INVENTION

A Process-Linked Data Management System in accordance with the presentinvention is now described with reference to FIGS. 1 through 23 and theabove definitions. As depicted in FIGS. 1 and 2, the system comprisesthe following hardware components:

Record Storage System (server) 101,

Electronic Clipboard 103,

Instrument Connection units 105, and

Radio Frequency LAN equipment 107.

The overall computer architecture is “Three-Tier Architecture” with verythin clients (incapable of storing records). The three tiers consist of:a data base server foundation layer 109 where all data is stored andsecured; a process or “middleware” layer 111 where the applicationprogram logic is performed; and a client layer 113 where the userinterface is presented. The data base server and the middleware serviceswill normally run in the same processor system, but may be run onseparate processor systems. The supported operating system for the database server and the middleware server is Windows NT 4. Supportedoperating systems for client are Windows NT and Windows 98. The RecordStorage System consists of an SQL compliant database engine housing thePLD data.

The middleware layer runs several functional applications:

The Procedure Manager 115,

The Procedure Execution Module 117,

The Procedure Development Module,

The Instrument Manager 121,

The Security Manager 123, and

The Report Manager.

The Electronic Clipboard is a display terminal or notebook computer forindividual operator use and having the following features:

Pen-based, and

Wireless networked.

Since the person performing the laboratory analysis can carry theterminal, it has wireless connections to the network infrastructure. Theclient application may be run on clipboards, notebook computers ordesktop workstations.

The Instrument Connection units are a family of small devices providingnetwork connection to the server, instrument connection capability andoperator panel connections. These units have the following features:

RS232 connections

Ethernet connection to network

Only translates protocol

The first Instrument Connection unit of the PLD system will support twoRS232 ports only. The Instrument Connection unit also provides forphysical attachment to the instrument to detect instrument changes.These devices may also have connections for infrared communication tothe hand held terminals.

The Record storage system is a network-connected server with thefollowing properties:

Is physically secure,

Is logically secure preventing unauthorized access to change data,

Is a high reliability system consisting of an enterprise gradeelectronic storage system and a remotely located parallel mirror of theprimary system,

Ethernet network connection,

SQL standard data base access,

Assures record management meta-data is collected, and

Provides a partitioning feature of the database to support activearchiving of historical data.

The connection to mobile clipboard devices in the lab uses IEEE 802.11standard RF Ethernet networking. The frequency is in the 2.4 gHz bandand is Direct Sequence Spread Spectrum (DSSS) mode of transmission.Units operating at 2 mbit/sec or greater are acceptable.

The basic user interface design is built on a consistent look for themajor functional screens. FIG. 4 demonstrates this look.

Each screen shares the following common areas:

Title Bar 127,

Menu Bar 129,

Info Area 131,

Caption 133,

Button Bar 135,

Left Navigation Bar 137,

Column Headings 139,

Data Area 141, and

Status Bar 143.

All screens are at 600×800 resolution. The display mode for each windowdepends on the screen resolution set for the computer. If the screenresolution is set at 600×800, all windows will appear in maximized mode.If the display mode is set higher than 600×800 then all windows willappear in window mode. Window mode windows may be moved around on thedesktop, but may not be resized.

The Title Bar is the typical Windows-type title bar, which carries theproduct name 145 and major function 147. It will also feature the upperright Windows-type buttons. The X button 149 will perform the samefunction as the “back:” selection on any screen. The Minimize button 151will be available to place the application on the task bar. There is noMaximize button.

The Menu Bar line contains a standard Windows-type menu. In principal,all functions that may be performed in the screen can be accessed usingthe Menu Bar with a mouse. Additionally, all functions may be accessedusing the keyboard arrow keys and accelerator keys are assigned to allfunctions.

The Info Area contains a unique string 153 identifying each screen and aback button 155.

The Caption displays a helpful description 157 of the data beingdisplayed in the Data Area. It also features a logo 159 at the rightedge, which will move when processing is taking place, but will remainsteady when user input may be accepted.

The Button Bar features single click buttons 161 for the most frequentlyused functions associated with the data display. These buttons do notreplace any functions available using the Menu Bar. Additionally, pulldown boxes 162 may appear, which will allow single selections fromfrequently used key word lists, causing a subset of data to bedisplayed.

The Left Navigation Bar is a vertical area on the left side of thescreen. This area will have icons 163 and captions 165 describing themajor functional modules of the system. The currently selected moduleicon will be displayed in a contrasting style to the unselected modules.When a selection event occurs on an icon, the system will exit from thecurrently selected module and open the module indicated by the newlyselected icon. Only modules that are available to the logged on userwill be shown in the Left Navigation Bar. The Left Navigation Bar maynot appear on screens used at deeper module functions.

The Column Headings 166 will appear whenever tabular data is displayedin the Data Area. These will indicate the nature of the data in eachcolumn. The headings will also be buttons which when pressed will causethe table to be sorted according to the data in the column. Successivebutton presses will alternately sort the table by ascending anddescending order of the selected column.

The Data Area is where the information specific to the screen functionis displayed. This may be a tabular display or any other formatappropriate to the data. When the display is tabular, the ability tohighlight a row and select an action using the highlighted row willgenerally be available. As this is a heavily used area of the PLD, largefonts and boxes are used.

The Status Bar contains at least the following information:

Logged on user name (the full name of the user who is currently loggedon) 167,

Terminal Session ID (an identifying number for the current terminalsession) 169,

Procedure Session ID (an identifying number for the current proceduresession 171, and

Date/Time Stamp 173 in the format mm/dd/ccyy hh:mm:ss am. (the time willbe local time taken from the server. The setting of the date and timeformat is controlled by the operating system local specification).

After login, only functions that the user is authorized to perform willappear in the various menu bars and navigation bars of subsequentscreens. Grayed out selections are used only to indicate selections thatthe user is authorized to do, but are not available in the currentcontext of the application.

When a columnar form is displayed in the data area, the user is able toselect an area of rows and columns and use standard Windows-type copyfunctions to place data on the Windows clipboard.

A calendar icon 175 is displayed on the right side of input boxes wheredates are entered. Pressing the calendar icon presents a pop up calendarfor date selection. The selected date is transferred to the data boxwhen the calendar pop up is closed. The internal storage of a time stampis a three-component record. The Windows data serial and time serial forlocal time at the server and the time zone offset are stored.

The background of all Data Entry Fields is white. When data is enteredbut not yet accepted into the system data storage, the field backgroundis yellow. Only one data field may be changed at a time in a panel withmultiple data boxes on it. When a data field is changed, the backgroundof all other data fields is changed to gray and the field is locked.Gray background is also used to indicate a locked field when a panel isinitially displayed.

The Procedure Manager provides the ability to view all proceduresregistered in the PLD. A registered procedure is one known to the PLDsystem by number, version and name. These are identical to theinstallation organization's designators for the procedure. The ProcedureManager has the ability to set up categories to aid in organizingprocedures. These are specific to the PLD system only. To register aprocedure, the location in the form of a Universal Resource Locator(URL) of the procedure must be supplied along with the status at thetime of registration. The URL and the status may be updated, as neededusing the Procedure Manager. All changes are recorded in the audittrail.

The registration information consists of the following items:

A key 177 consisting of the procedure number and version,

The procedure name,

The procedure category,

The procedure status,

The procedure URL, and

The registration audit trail.

Procedure storage may be in the database of the PLD or in a corporateprocedure store. The protocol field of the URL will indicate the type ofstorage system. The access methods supported are Windows NT file serverand Documentum. Supported file formats for procedures are portabledocument format (.pdf) and rich text format (.rtf). Some registeredprocedures may be stored in the PLD database while others are stored ina corporate system at any time. Import and Export functions are providedto transfer procedure files between the PLD and standard disk files.

The logged-on User ID is passed to the corporate procedure store whenaccessing approved procedures. Proper access controls are theresponsibility of the corporate store that is expected to return eitherthe test procedure or, an error code.

Procedure status may be In Draft, Process, Current or Superceded. Accessto procedures will be granted to individual users based on procedurestatus. If the location of a procedure changes as a result of a newstatus, the URL used to locate that procedure must be manually updatedusing the Procedure Manager screen.

The Procedure Manager links to the edit facility for procedures storedin the PLD. Users who are authorized to edit procedures will bepresented with the link. The procedure will be fetched and passed to theedit facility listed in the system installation options. The editor isusually a standard word processor such as Microsoft Word. Upon a saveoperation from the editor, the modified procedure will be storable onlyin the PLD with a “Draft” status. Customer corporate SOP's for testprocedure validation and approval will be followed to change the statusof an edited procedure and cause it to be stored in the corporate systemif required. These SOP's must include mechanisms for updating theprocedure registration database in the PLD.

The registered procedure display screen, FIG. 5, shows the currentdocument revision of the current version of the registered procedure. A“View” menu option provides access to all versions and revisions ofprocedures registered. The display may be filtered on any of the columnsshown. Deleting a procedure registration record may be done when theprocedure status is superceded and no procedure sessions reference theprocedure.

The Procedure Execution module presents a list of procedure sessionsstored in the PLD, FIG. 6. Only procedure sessions where the securityattributes match those of the logged-on user will be displayed. Thecommon filters of user and status are available in pull down lists onthe Button Bar. Any procedure session that the user is authorized toaccess may be viewed by changing the filter settings. The user canmodify the individual default filter setting. The initial default filterwill show the logged-on users in process procedures.

There will be a large number of procedure sessions stored in the PLD.Therefore a rich filter function is provided to allow multipleselections from each column of the procedure session table. Theprocedure session ID is a two-part identifier. The first part is theunique combination of procedure number, version and revision, and sampleidentifier. The second part is a sequence number that indicates multipleruns of the same procedure on the same sample. An example of a proceduresession ID is P0403.897 LOT5798:02. This is the second session ofprocedure P0403.897 for LOT5798 in the system. The procedure version andrevision are displayed in individual columns. Procedure terminal statusmay be:

Open

Closed

Open sessions are sessions currently in use by laboratory personnel at aterminal. Closed sessions are not active on any terminal. A proceduresession may be open on only one terminal at a time. Access by a secondterminal is not allowed. If an open terminal session record is found,the identified terminal is queried by the system to verify that theterminal session is still active. The terminal session softwareautomatically maintains the terminal status of the procedure session. Aprocedure session may be connected to only one terminal session at atime. A terminal session may be connected to several procedure sessionsof the same procedure at one time. Procedure session status may be:

In Process

ReDo

Completed

Reviewed

Reviewed and Locked

Approved

In Process sessions are uncompleted sessions. All data and annotationitems may be added or changed as needed to complete the session. Whenall required data has been collected, and all data values are withinlimits specified in the test procedure or have user-entered reasoncodes, the procedure status may be changed to completed. No data entriesmay be added or changed in Completed sessions, but a reviewer may addstep annotation. The reviewer may change the status to Reviewed,Reviewed and Locked, or back to In Process if data needs to becorrected. No data entries may be added or changed in Reviewed sessions,but a reviewer may add step annotation. The reviewer may change thestatus to Approved, Reviewed and Locked, or back to In Process if dataneeds to be corrected. No data entries or annotation may be added orchanged in Reviewed and Locked sessions. The reviewer may change thestatus to Approved. Authorized users may change status to ReDo. No dataentries or annotation may be added or changed in Approved sessions. Thestatus of the procedure session may not be changed, except thatauthorized users may change status to ReDo.

Completed, Reviewed and Approved status change may be performed byauthorized individuals using the “Procedure” menu 177 of FIG. 8.However, no person will be allowed to Review or Approve a proceduresession where they initiated or completed the session. Electronicsignatures are required when the status is changed to Completed,Reviewed and Locked, Approved and ReDo.

Selecting “New” 179 on FIG. 6 may start a new procedure session. Thescreen changes to a list of Approved Procedures registered in the PLD,FIG. 7. The required procedure may be highlighted using the Categorycolumn 181 and the column sort 183 features of the User Interface. Oncethe required procedure is selected, the new session is begun using the“Start” button 187. A dialogue box as depicted in FIG. 13 is displayedfor entry of the Sample Identifier, or multiple sample identifiers forthe new session(s). A rich filter function is available as the pop-upmenu depicted in FIG. 14 for multiple selections in each displayedcolumn. Normally, the current approved procedures 193 are displayed. Ifa prior version of a procedure needs to be used, the “All Versions”selection 195 will show prior versions of procedures.

The indicator 199 for step annotation may be pressed to display theannotation in a pop up window. This provides quick access to specialcomments recorded about the procedure session. Once a procedure sessionor a new procedure is selected, the procedure is retrieved using the URLin the Procedure Manager for that procedure number and version. The PLDlanguage in the procedure is interpreted and used to display the datapresent in the PLD database, FIG. 8. The data display of the procedureis not in table form. The procedure execution display consists of threesections. The upper section 201 is the procedure text where each step,as delineated by the step mark in the PLD language, is displayed. Theactive step is indicated by colored marking. “Back” 204 and “Next” 205buttons control the up and down movement of the highlighting to identifythe active step.

A scroll bar 207 on the right side of the procedure display area allowsmovement by line or page through the procedure. Clicking anywhere on astep shown in the display area causes the current step to be set to thatstep.

When multiple procedure sessions have been started or opened, aselection bar 209 is displayed above the status bar. The selection barshows all of the sample identifiers 211 of currently open sessions.Pressing one of the sample identifiers will cause that procedure sessionto be displayed.

In some steps, PLD specifications for data collection will appear. Theprocedure execution module uses these specifications to displayappropriate data collection boxes 213 in the data collection area 214.Meta-data boxes 215 will be automatically generated in the middlesection, the meta-data area 217. The meta-data boxes collect instrumentidentity and calibration information. The PLD registration informationis accessed to determine what kind of data collection activity isappropriate for the instrument. The data collection boxes provide inputfields 219 for user data entry, electronic capture display and file ordatabase capture displays in the lower area. The middle and lower 221sections are displayed as required by the data collection specificationsin the procedure. The height of the lower area is dynamically adjustedto fit all data boxes in the step up to two lines of data boxes. Whenthe area needed for data collection boxes exceeds two lines of databoxes, a vertical scroll bar will be displayed on the right side of thedata collection box area. The meta-data middle area is displayed asrequired when an instrument is used in the step. Only one instrument canbe used in a PLD step. When the active step has no data collectionrequirements, the entire data area is used to display the test proceduretext.

The screen of FIG. 9 includes a data collection area that allows theanalyst to record the instrument readings manually or by capture fromconnected instruments. The meta-data area above the data area providesfor entry of the required information. Recording the calibration dateand due date is enabled by an installation option.

FIG. 11 shows a data collection area generated for a networkedinstrument. In addition to the file location, there is a need to collectinformation that represents the correct location of the file and a keyto identify the location within the file where data will be extracted.When the instrument registration specifies capture of instrument methodand/or raw data files, an additional URL box will be displayed for eachspecified file.

During execution of a procedure, annotation may be added to any stepusing the “Annotate” button 223 or menu selection of the screen shown inFIG. 9. A text box appears for entry of the annotation. The annotationmay be changed at any time, invoking a standard PLD audit trail.

More than one procedure session may be open in the same terminal sessionas long as all open sessions are using the same procedure number andversion. Data items which are common to all open procedures such asstandard prep, reagents, mobile phase information, etc. may be enteredinto one procedure and transferred to all other open procedures by apop-up menu selection (FIG. 9A). Copying data may only be done withvalues that are already recorded in the PLD database. Use of the copyselection 231 overrides the PLD input data specification in theprocedure for the data in the other procedures. Another selection 233provides an input override to copy information from another proceduresession that is not open. This override can only read data from anotherprocedure session that has the same procedure number and input fieldname.

A concise listing of all data collected is available from the datareview function, FIG. 10. The display shows the name of the field andthe latest value for each data item and displays blanks for any itemsnot yet collected. The meta-data is displayed in columns after the data:Date, Time, Who, EIN, Reason Code and Capture Mode. The first column 235contains an indicator 237 for data audit trail. Selecting the indicatorcauses an expansion or contraction of rows showing the complete datahistory. The second column 239 displays an out of limit indicator 241for any data where the value exceeds the limits in the test procedure.The “OK” button 243 will return to the procedure execution display. Thefourth column 245 displays an indicator 247 for supporting data.Supporting data may be either captured from an instrument or input fromanother procedure session. If the input data from another proceduresession has a newer timestamp than the current session, the supportingdata indicator will change to indicate so. Pressing the supporting dataindicator will cause the supporting data to be displayed in a pop upwindow using a viewer appropriate to the data format.

The standard data entry box, FIG. 15, consists of seven main elements(left to right):

The audit trail selector 251,

The out of limit indicator 253,

The supporting data selector 255,

The old data indicator 257,

The variable name label 259,

The data entry box 261, and

The action button 263.

The audit trail selector 251 appears whenever there is more than oneentry and when the original entry has a user entered reason code. Whenpressed, the selector will cause the audit trail pop up window, FIG. 12,to appear showing the expanded detail audit trail of the individual dataitem. The column headings and actions are the same as those available inthe data review function.

The out of limit indicator 253 will be displayed whenever the currentvalue for the data box does not conform to limit specificationscontained in the test procedure.

The supporting data selector 255 appears whenever the input data streamfrom an instrument has been recorded. Pressing the indicator willdisplay a viewer for the input data stream. Recognized data streams suchas graphic files, text files, etc. invoke standard viewers launched asan embedded process in the PLD. Non-standard data streams invoke ahex-ascii viewer. The supporting data indicator 255 on a data entry boxis controlled by the latest entry in the audit trail. When viewing theaudit trail, a supporting data indicator will appear for each entry inthe audit trail as appropriate.

The old data indicator 257 will be displayed whenever any source datafor calculated values is newer than the calculated value.

The data entry box 261 provides for entry of alphanumeric text. Thevariable name 259 from the procedure is displayed over the box. Somedata boxes may have an associated format specification in the PLDspecification. Manually entered values will be checked against theformat specification when the action button 263 is pressed. If theentered value conflicts with the format specification a warning dialogueis displayed allowing the user to change the entered characters prior torecording the value in the PLD database.

The action button 263 optionally appears whenever the value in the entrybox has not been committed to the PLD database, when an instrumentcapture action is available or a calculation can be done. These actionbuttons are used:

Commit data,

Capture data from a connected instrument,

Capture data from a networked instrument,

Transfer data from other PLD procedure sessions, and

Calculate data from other PLD data boxes.

The commit data button appears whenever an uncommitted value appears inthe box and no other button could appear. Keyboard and pen entry is usedto place the data value in the box. The user may edit the value tocorrect for typographical errors. When the value is correct, the commitdata button is pressed, recording the value in the database. Afterrecording the data the button is no longer displayed. The value may bechanged at a later time by editing the value displayed in the box. Whenthe value is changed, the commit data button is once again displayed.The modified value will be recorded when the button is pressed. Thereason code dialogue will be displayed for all modified values.

The capture data from a connected instrument button appears when themeta-data ID selects a registered instrument that is connected to thePLD system. The button will indicate and trigger electronic capture ofthe data. The captured data is recorded in the database and displayed inthe data box. The button is removed from the display when the data isrecorded. The data may need to be re-captured for a variety of reasons.Initiating a recapture is done with a right mouse menu selection causingthe electronic capture button to re-appear. The ability to manuallychange electronic data is controlled by an installation option. Whenmanual changes are allowed, a keyboard or pen entry that changes thedata in the box will cause the commit data button 263 to appear. In thecase of any kind of change the audit trail, including reason code willbe recorded.

The capture data from a networked instrument button 297 appears when themeta-data ID selects a registered instrument that is connected to thecorporate network. This button functions like the connected instrumentbutton, but uses the expanded meta-data bar 299 to identify the sourcedata file.

Multiple data boxes parsed from a single data stream from an instrumentmay appear in a step. When this condition occurs, only the first of therelated boxes will have an action button. The remaining related boxeshave data captured at the same time as the first box.

The “transfer data from other PLD procedure sessions” button 301 appearswhen the data capture specification specifies a related PLD proceduresessions. This button functions like the connected instrument button,but uses the meta-data bar to identify the procedure session where thedata is read. The initial procedure session displayed in the meta-databar is the one where the sample ID matches the current procedures sampleID, if it exists. All procedure sessions for the related procedure areavailable in the selection list.

The calculation button 303 is displayed when a formula is specified inthe PLD specification. Calculations may only use data from other databoxes in the same procedure session. If data is needed from sourcesoutside the procedure session, a separate data capture box must be usedin the procedure.

When data is changed, a standard dialogue 305 is displayed that requiresentry of the reason for the change. The dialogue consists of a pull downlist of previously established reason codes. The most recently usedreason code is remembered for the terminal session and displayed as thedefault value the next time the reason code dialogue is shown. Thelogged-on user may be granted different levels of reason code authority:use predefined reason codes only; add special reason codes as needed;and add new reason codes to the list. If the user is limited topredefined reason codes, one of the displayed reason codes must beselected. If the user can enter special reason codes, the text isentered in the list box area. When the user is authorized to add newstandard reason codes, the new code is entered in the list box area anda check box is displayed to make it a standard reason code. Aninstallation option can be set that will require entry of the userselectronic signature to record the reason code.

There may be a condition when an action is needed that is beyond theauthority of the logged-on user. An alternate user may be added to theterminal session using a menu selection. While the alternate user isadded, all security tests are based on the added user authority and alldata recorded is identified with the alternate user's ID in the audittrail. The alternate user's electronic signature is required for anyneeded signatures. When the alternate user's authority is no longerneeded, the alternate user must exit the session. The original userremains as the logged-on user with his or her authority.

The procedure interpreter reads the PLD specifications found in the testprocedure and causes the data collection 214 and meta-data 217 areas tobe displayed. The test procedure is displayed in the same format as itis viewed in its normal editor. Printed copies have essentially the sameformat also. Existing test procedures are converted to PLD testprocedures by the addition of the PLD language for data collection. Theoriginal procedures may be in paper form or a variety of electronicforms. The converted procedures need to be stored in a data formatacceptable to the PLD. In some cases, there may be reasons to continueto use paper test procedures. The PLD may still be used for primary datacapture by creating a test procedure digest consisting of the PLDlanguage for each step in the procedure where data is captured. Thedigest is stored in the PLD. Validation and linking of the digest to theapproved procedure are handled by the customer's corporate SOP for testprocedure approval.

The PLD language consists of readable keywords, tokens and variablenames as illustrated by the following table, that do not interfere withthe clarity of the test procedure instruction to the operator.

Step 1:

This is an example of creating an input data box titled “Input data”.

|* Input Data*|

|&

Step 2:

This is an example of reading a weight from a balance.

|* Instrument Value=EIN: Balance: weight_g, F3.4*|

|&

Step 3.

This is an example of comparing an entry to a limit.

|* Reaction Temp *|

|* LIMIT: Reaction Temp>20: “Temperature is too low.” *|

|&

Step 4:

This is an example of a calculation.

|* Calc Value=Input Data * 3, F5.2 *|

|&

Step 5:

This is an example of obtaining readings from a network instrument.

|* 10% Distribution=EIN:Particle Size: 10_PERCENT_um *|

|* Mean Distribution=EIN:Particle Size: MEAN_um *|

|&

|* START REPORT *|

VelQuest Corporation

Initial Datá: |*Input Data *|

Temperature: |* Reaction Temp *|

Small Size: |* 10% Distribution *|

Median Size: |* Mean Distribution *|

|* END REPORT *|

The PLD specifications are usually placed at the end of each proceduralstep that collects data. A step delimiter (|&) is placed at the end ofeach logical step in the test procedure. A special, delimited section(from “|*START REPORT*|” through “|* END REPORT*|”) is placed at the endof each test procedure to provide a full data report for the datacollected. This form is in a WYSIWYG format, with data box fill-inspecified by the data field names taken from the body of the procedure.

The main statement types implemented in the PLD specification languageare:

Selection specification,

Activation specification,

Data input specifications,

Data limit specification,

Data forwarding specifications, and

Data reporting specifications.

The selection specification provides a multiple choice or check boxfacility that provides classification of the type of sample or type oftest being performed. Each multiple choice item has an integer value.Each check box item has a true or false value. Activation tags in otherdata specifications can test the value of a selection item.

The activation specification refers to a selection variable name andvalue. When the value in the specification matches the value in theselection variable, then the PLD commands for the current step areactivated.

The data input specification will support data capture manually from thedisplay terminal, directly from connected instruments, from data fileson networked instruments and from data stored in other PLD proceduresessions. Transferring data from other PLD procedure sessions supportsthe consolidation of multiple analyses into a batch record that might bemaintained in the PLD system. It also supports incorporation of datafrom instrument calibration, reagent prep, and standards prepprocedures.

The data input specification consists of the following elements:

Data variable name,

Optional count

For instrument readings

Instrument keyword—EIN

Source EIN variable name

Reading name

For input from other procedure sessions

Procedure keyword—VDA

Input procedure number

Input variable name

For calculated results

=formula

Optional Format specification

The count expression is either an integer that refers to a specific itemof the array, or a whole array indicator followed by a count variablename or array size for operating on all elements of the array. Thereading name must be the same as a field identifier set up for theinstrument in the instrument parse library. The format specificationincludes controls on the type of entry, significant figures, decimalplaces, rounding and truncating. An installation option specifies therules to be used for rounding the final result of calculations. The datalimit specification tests the value in a data input box against one ormore numerical limits. If the value is outside the limit a messagespecified in the limit specification is displayed for analysts'acknowledgement.

The data limit specification consists of the following elements:

Limit: keyword,

Data variable name,

Limit expression, and

Alert message text.

The limit specification must appear in the same step with the data entryspecification it applies to. The limit expression is tested with thedata variable value. If a result is false, an alert 319 will bedisplayed using the alert message text. Two means of acknowledging thealert are available. One simply clears the alert and returns to theprevious screen. In this case the system-generated indicator identifyinginitial data is applied to the value. The other mean causes the reasoncode dialogue to be displayed as in FIG. 15A, allowing a user-enteredreason code to be applied to the value. An installation option willenable acceptance of an out-of-limit entry by entering a reason code.

Data forwarding specifications control the movement of selected data toother computer systems or to other procedure sessions stored in the PLDsystem. The data forwarding specification will be able to specify outputformatting suitable to create a transaction file for other systems, suchas LIMS and chromatography data systems. The data forwardingspecification consists of the following elements:

Forward: keyword

Forwarding action specification

For transaction files

Destination URL of transaction file

List of data field names to be included

For procedure sessions in the data base

Procedure ID

Variable name where the data will be stored

The forwarding action specifies when the values should be forwarded. Thepossible values are:

In Process,

Completed,

Reviewed, and

Approved.

Forwarding while in-process causes the forward button to appear when thestep is selected. Forwarding after completion, causes the Review orApproval to be activated when the procedure status is changed. The stepscontaining the forwarding specification will appear in the proceduredisplay area 201. The person performing the review or approval mustactivate the forwarding function by pressing the forward button. Arecord of the forwarding action is stored in the standard PLD audittrail. Forwarding will cause a forward button to be displayed in thedata box area for the step. The meta-data area will show the URL fromthe procedure and a key field. The final URL and the key field areentered by the analyst before pressing the forward button.

The standard technique to transfer data to another system from the PLDsystem is a transaction file. The file is generated according to theforwarding specification in the PLD commands. The destination URL is anetwork file specification selected at the time of data transfer.Specific forwarding interfaces for a variety of other systems may bemade.

Data reporting specifications provide the WYSIWYG format for a formatteddata report that is available at the end of each procedure. The dataforwarding specification consists of the following elements:

The Report delimiter,

The WYSIWYG layout of the data report,

The data field references, and

The End delimiter.

The data report appears like a form in the procedure. Within the form,data field references cause the values of the data fields to bedisplayed when the report is viewed. Although not the only syntaxuseable for this purpose, the following is the BNF Definition of PLDCommand Syntax of the preferred embodiment:

PLD_step=>text|PLD_statement *[text|PLD_statement]

bar&

PLD_statement=>barstar data_statement|limit_statement

|select_statement|activate_statement|forward_statement

|report_statement|

report_variable starbar

data_statement =>arrayname [=data_source ] [,formatspec ]

data_source=>instrument|calc|PLDsource

instrument=>EIN: source_ein: sourcefield

source_ein=>name

sourcefield=>name

calc=>expression

PLDsource=>PLD:procid:arrayname

formatspec=>ftype length [dp length]

ftype=>F\I\S

length=>digit *[digit]

limit_statement=>LIMIT: arrayname compexp: false_action

select_statement=>SELECT: selectvar=set

activate_statement=>ACTIVATE: selectvar=|< >

text_string|set

forward_statement=>FORWARD: forward_action, forward_spec

forward_action=>In Process|Completed|Reviewed|

Approved

forward_spec=>transaction_forward_spec|

procedure_forward_spec

transaction_forward_spec=>url_template: arrayname *[,

arrayname]

procedure_forward_spec=>procid:arrayname=arrayname *[,arrayname=arrayname]

selectvar=>name

procid=>textstring

report_statement=>START REPORT|END REPORT

report_variable=>arrayname|report_predefined

report_predefined->PLD_Analyst|PLD_SampleID|PLD Date

|PLD_Reviewer|PLD_Approver

url_template=>

protocol://machine_name/[path_name/]file_name

protocol=>file

machine_name=>text

path_name=>text

file name=>text

false_action=>text_string

compexp=>compop expression *[logicop compop expression]|=set

expression=>[unop] [(] [unop] arrayname|expression|

number [biop arrayname|expression|number ] [)]

set=>={text_string, text_string *[, text-string]}

arrayname=>varname|varname (count )

count=>digit *[digit]|varname

varname=>name

number=>[unop] digit *[digit][dp digit]*[digit]

compop=>=|>=|<=|< >|=<|=>|!=

logicop=>and|or

unop=>−|+

biop=>+|−|star||{circumflex over ( )}

text_string=>“text”

text=>anychar*[space|anychar]

name=>alpha*[alphanum]

alphanum=>alpha|digit

anychar=>% 01% ->% 7 f%

alpha=>

A|B|C|D|E|F|G|H|I|J|K|L|M|N|O|P|Q|R|S|T|U|V|W|X|Y|Z|

a|b|c|d|e|f|g|h|i|j|k|l|m|n|o|p|g|r|s|t|u|v|w|x|y|z

digit=>0|1|2|3|4|5|6|7|8|9

dp=>.

barstar=>%7 c%%2 a%

starbar=>%2 a%%7 c%

star=>%2 a%

bar=>%7 c%

Procedure Development provides a means to create or edit experiments andcollect data. Each experiment is stored as procedure text in the PLDdatabase under an experiment name and experiment number. Each time a newexperiment is started both a new session and new experiment text will begenerated. When the identifier for the experiment matches a previouslyentered identifier the next sequential experiment number is applied.

The first screen is a list of experiment sessions, FIG. 6. Anyin-process session may be resumed, or a new session may be started. Whena new session is started, a choice is presented to start with emptytext, or to start with the text of a previous experiment or a standardprocedure. If a previous experiment is selected, a list of developmentexperiments stored in the PLD database is presented for selection. Theprevious text is copied into the experiment text area and is preparedfor data collection. Experiment text is stored like procedures, but in aseparate area that is invisible to procedure manager and procedureexecution. When a set of experiments leads to the preparation of a draftprocedure, the draft procedure is handled by procedure manager andprocedure execution.

When new experiment sessions are started, the experiment identifier andthe experiment name are taken from the experiment text records. The testitem identifier is entered in the same way a sample ID is entered in theProcedure Execution module. A free text field is also provided to entera description of the experiment session;

During the course of running the experiment, all PLD commands operateand provide normal data collection facilities. In addition, the text ofany step may be edited by pressing the “Edit” button when the highlightidentifies the step. However, collecting data restricts editing to onlythose steps appearing after steps in which data has been collected.

A text-editing screen is displayed with the existing step text. Theinstructions to the analyst and the PLD commands may be edited. When the“Finish” button is pressed, the revised step text is displayed in theprocedure execution window. Appropriate Meta-Data fields and DataCollection boxes will be displayed and data collection may be performed.While an experiment session is in process, the associated experimenttext is stored in the PLD database in the same way as registeredprocedures. The experiment text is updated in the database at thecompletion of each edit operation. In this way the correct state of theprocedure text is displayed when the experiment is displayed in aterminal session. When the experiment is changed to completed status, nofurther changes to the experiment text may be performed.

The Procedure Execution module is used when there is a need to repeat anexperiment to collect more data without changing any of the experimenttext. Experiment information is displayed in Procedure Execution asfollows:

Experiment ID Procedure Number

Experiment Category Procedure Name

Experiment Session Procedure Session

Experiment Item not shown

Experiment Description not shown

The Procedure Development module has a reporting mode that integratesthe procedure text with the collected data. Each defined PLD step textis displayed, followed by the meta-data and collected data in a similarformat to that shown on the screen. This report may be reviewed on thescreen and printed.

The Instrument Manager provides the ability to register instruments inthe PLD system. Any kind of instrument may be registered from simpleindicating devices such as mercury thermometers to computer-controlleddevices such as chromatographs. Some devices may have electronicconnections to the PLD system. The entry screen of the instrumentmanager is the list of registered instruments, FIG. 16. The list ofregistered devices is presented with a simple sort facility on devicetype. Device type is an arbitrary grouping category entered at the timeof device registration. New devices may be registered by pressing the“Register” button. Registration information is entered in the screendepicted in FIG. 17. Registered devices are initially registered asunconnected devices. The “Update” button runs the instrument connectionsetup. The series of setup screens provides for input of the followingparameters:

Type of connection,

Mode of data capture (Electronic, File),

Commands to device,

Data streams from device,

Creates data field keyword for PLD method language, and

Specifies recording the input data stream.

The type of connection specifies the instrument's physical outputconnection, FIG. 18. The PLD Instrument Interface box (Ibox) is used forall connection types except a network connection. Depending on theconnection type, an initialization string is defined by the instrumentadministrator to set parameters such as baud rate or data width. The PLDIbox accepts these specifications and configures itself and theinstrument as needed. The address or computer name and the port numberof the instrument are also specified with the connection details.

There are two modes of data capture: triggered or collected throughcommunications interface and network connections to the instrument. Theusual network connection is to a computer running the instrument. Inthis case the input data stream is a file or data base query from thecomputer. In either case an input data stream may yield only one datavalue or multiple data values. Multiple data values are obtained fromonly one input data stream. The input data stream may be recorded in thePLD database.

Supporting data consisting of method files and instrument resident rawdata files can be recorded in the PLD database together with the resultfiles. Within the interface specification, each data collection activityis identified by a command name, FIG. 19. Each named command may have atrigger specification for the reading. If no trigger is required, thespecification is left blank. A parsing specification to controlextraction of data values from the input data stream must be supplied,FIG. 20.

To define parsing, an example return string must be available to theinstrument administrator. The example may be obtained by pressing the“Test” button 349 that will acquire an actual data stream from theinstrument and display it. Alternatively an example data stream may betyped into the display area 351. In both cases the data stream may beedited to enable a complete parsing specification. Once the example datastream is displayed, any number of individual data field specificationsmay be entered. Individual data field specifications consist of thefollowing elements:

Format specifier,

Line and character count to start,

Start character string, and

Ending character string.

These specifications are largely entered graphically using highlightingon the example data stream to locate individual source areas.

Networked instruments usually have large data files covering a multitudeof samples. For each command, the location of the data in the input datastream may depend on a key string or a positional count. The meta-dataarea of Procedure Execution provides input of key information to locatethe correct area of the file for a given procedure session. The rulesfor finding the correct area of the file using the key are entered inthe instrument setup, FIG. 21. These rules are based on matching the keystring in the input stream, or counting blocks of data in the inputstream. These parameters may also be imported from a library of previousinstrument setups.

For each instrument, an option 350 is provided for controlling therecordation of the supporting data stream that is used to parse theresulting data values. The saved supporting data stream is stored in thePLD database together with the results.

The Security Manager consists of two major subsystems:

The User Authentication system and

The User and PLD Maintenance system

The User Authentication system is invoked whenever a user attempts togain access to the PLD system, and when user authentication is requiredfor controlled events such as electronically signing a document orentering a reason code.

The User and PLD Maintenance system is used by the PLD SystemAdministrator to authorize individuals for access to the system and toestablish system installation parameters

To gain access to the PLD system, a valid User ID and password isrequired. These are entered in a dialogue screen (FIG. 22) and validatedagainst the appropriate user database. After successful identificationthe user's authorized activities and the user's security attribute listsare loaded into the system for reference by other modules. Aftersuccessful login, a reminder is displayed warning the user not to leavethe terminal unattended.

Optional biometric devices may be used to enhance user identification.The biometric devices are installed at all workstation computers whereaccess to the PLD system is required. Personal terminal devices such aselectronic clipboards and notebook computers do not have associatedbiometric devices. These devices use an infrared or other link toassociate the personal terminal with one or more workstation computersequipped with both a biometric device and an IR or other port. After theIR or other link is established, the user may log into the personalterminal using the biometric device on the workstation.

Two modes of user identification are available. The first mode validatesthe User ID and password entries by the operating system. The PLD thengrants access based on the PLD records for the User ID logged-onto theoperating system. The second mode validates the User ID and passwordentries by comparing to records stored in the PLD database. The PLD thengrants access based on the PLD records for the User ID logged-onto thePLD system.

Since the PLD programs are read from the server, a valid network loginis required in either case to provide access to these programs. When theoperating system is used for user identification, no further loginscreens will be displayed. When the PLD system is used for useridentification, the PLD login screens will be displayed at the start ofthe PLD application. When the identification uses the PLD database,installation options specify the frequency of password change. The loginscreen has an option to change the password by entering the old passwordand a new password with double confirmation. If the time specified inthe installation option has expired, the change password dialogue willbe presented to the user with no other actions available except tochange the password. The new password entered must meet installationoptions for length and uniqueness over the specified number of previouspasswords.

The User and PLD Maintenance system provides the registration functionfor authorized users and provides for setting PLD installationparameters.

The identification of users by User ID and password is the fundamentalidentification mechanism. An installation parameter determines if theoperating system (Windows NT) is the user database, or if the PLD userdatabase will be used to identify the user. When a private user databaseis in effect, the user maintenance screens provide for entry of new UserID's and passwords. When the operating system user database is ineffect, the user maintenance screens will provide access to theoperating system list of users, allowing a subset of those users to beadded to the PLD user database. Regardless of the identification database used, supplemental information and two major categories of userauthority information is stored in the PLD data base:

1. User ID

2. User department

3. User status

4. User Full Name

5. Authorization of activities

6. A plurality of security attribute lists

The PLD administrator can add users, modify the descriptions andsecurity attributes of users and inactivate users, using the menus. Overtime some users will no longer be authorized to use the PLD system.However these users may be associated with recorded data. Therefore theUser ID and Full Name and inactive status will be permanently maintainedin the PLD database. The User ID may not be issued to any otherindividual. Inactive users may be reactivated at a later time. When onlyone PLD administrator is defined s/he may not be inactivated. The PLDadministrator may not change his/her record.

Activities are defined as operations that may be performed using the PLDsystem. For example, editing a procedure, running a procedure andapproving a procedure are activities in the Procedure Execution module.Each functional module of the PLD system specifies the activities thatmay be authorized. These activities will be presented as a list groupedby module. When additional modules are installed in the system,additional activities will appear under the new module heading in thesecurity manager. The security manager has two activities that may beauthorized: user maintenance and PLD option maintenance. During initialinstallation of the system an add user dialogue is displayed to cause aninitial PLD administrator to be assigned. This dialogue will occur afterthe selection of the mode of user identification database occurs. Aspecific individual will be identified.

Security attributes are a set of fields attached to each data record.The exact number of fields may be varied to suit the application. Thesefields provide a set of descriptors for each record that are used toallow access to the record. Each user record has the ability to store amultitude of values for each of the security attributes. The names bywhich users will know each of the security attributes are setup as aninstallation option. These names are used for display only. Internaloperations involving security attributes are identical for allattributes regardless of user assigned names. The number of securityattributes actually used may be limited by an installation option. Whenlimited, screens displaying the attributes will show the limited number.Records generated will have excess security attributes filled in with a“match all wildcard” value. When the number of security attributes isincreased at a later time, old records will match any value in the userdatabase. Users may have an unlimited list of specific values for eachsecurity attribute including wildcard values with sub-strings. For eachvalue, an access level of either read or write will be assigned. Accessto records is granted by matching all security attributes in the recordwith the list of security attributes for the logged-on user. The mostlimited access is granted.

The Registered Users screen, FIG. 23, is the entry screen for usermaintenance. It provides access to each registered user as well asaccess to system wide installation options on the “System” menu pulldown.

Each installation may tailor the operation of the PLD system to conformto its SOP's. The following options are available:

1. Location of User Identification data base

2. Supervisor approval for original data changes

3. Number of Security Attributes

4. Names of all Security Attributes

5. Password expiration interval

6. Required length of passwords

7. Number of previous passwords which must be unique

8. Allow manual entry of data from electronically connected instruments

9. Allow override of electronic data capture from instruments

The Report Manager maintains a list of stored reports, together with therequired information to run those reports. Each report listing, asrepresented in FIG. 24, contains these elements:

Report Name 355,

Report ID 359,

Report Version 357,

A report may be selected by normal selection methods. When selected torun, the report engine is started and the saved specification for thereport are presented to the engine. If any tailoring of the parametersis needed, it is performed by the report engine software. New reportsmay be prepared using the report engine software. A dialogue 365 for thename of the report is presented. Upon saving the report, the ReportAuthor, Date Created and Report Version are automatically entered.

Those skilled in the art will recognize that there are many variationsof the invention that are within the scope of the invention, therefore,the invention is to be defined only by the limitations and theequivalents thereof which the following claims set forth.

What is claimed is:
 1. A method of electronically managing measured,calculated and observed data of the type requested by pre-existingprocedures and obtained through analytical instrumentation or byobservation, said method comprising the steps of: providing a datamanipulating device which contains an information management program;loading a single set of instructions containing said pre-existingprocedures into said data manipulating device, wherein said datamanipulating device creates a set of procedural instructions; providingsaid procedural instructions to said program, for use thereby in thegeneration of a record database of a given lot of products and a reportformat; providing said procedural instructions to one or both of saidanalytical instrumentation and an observer, for use thereby in thetaking of one or both of said measured and observed data and informationfrom which said calculated data is generated; confirming the calibrationstatus of said analytical instrumentation by said program, and whereinsaid taking of said data without said confirmation of proper calibrationis denied; retrieving any taken of said measured and observed data intosaid record database; retrieving any taken of said information into saidprogram for generation thereof into said calculated data and thenretrieving said calculated data into said record database; combiningsaid one or more of said measured, calculated and observed data fromsaid record database with said report format by said program, to producea final report therefrom; and wherein said data and information are onlyrecorded within said record and said final report.
 2. A method ofelectronically managing measured, calculated and observed data of thetype requested by pre-existing procedures and obtained throughanalytical instrumentation or by observation, said method comprising thesteps of: providing a data manipulating device which contains aninformation management program; loading a single set of instructionscontaining said pre-existing procedures into said data manipulatingdevice, wherein said data manipulating device creates a set ofprocedural instructions; providing said procedural instructions to saidprogram, for use thereby in the generation of a batch record databaseand a report format; providing said procedural instructions to one orboth of said analytical instrumentation and an observer, for use therebyin the taking of one or both of said measured and observed data andinformation from which said calculated data is generated; retrieving anytaken of said measured and said observed data into said batch recorddatabase; retrieving any taken of said information into said program forgeneration thereof into said calculated data and then retrieving saidcalculated data into said batch record database; combining said one ormore of said measured, calculated and observed data from said batchrecord database with said report format by said program, to produce afinal report therefrom wherein said data and information are onlyrecorded within said batch record and said final report; and confirmingthe calibration status of said analytical instrumentation by saidprogram, wherein said taking of said data without said confirmation ofproper calibration causes said taken data to be identified as improperdata in both said batch record database and said final report.
 3. Themethod of claim 1 wherein said retrieving said one or more of saidmeasured and said observed data into said record database and saidinformation into said program is by wireless communication.
 4. A methodof electronically managing measured, calculated and observed data of thetype requested by pre-existing procedures and obtained throughanalytical instrumentation or by observation, said method comprising thesteps of: providing a data manipulating device which contains aninformation management program; loading a single set of instructionscontaining said pre-existing procedures into said data manipulatingdevice, wherein said data manipulating device creates a set ofprocedural instructions; providing said procedural instructions to saidprogram, for use thereby in the generation of a batch record databaseand a report format; providing said procedural instructions to one orboth of said analytical instrumentation and an observer, for use therebyin the taking of one or both of said measured and observed data andinformation from which said calculated data is generated; retrieving anytaken of said measured and said observed data into said batch recorddatabase by wireless communication; retrieving any taken of saidinformation into said program for generation thereof into saidcalculated data by wireless communication and then retrieving saidcalculated data into said batch record database; combining said one ormore of said measured, calculated and observed data from said batchrecord database with said report format by said program, to produce afinal report therefrom wherein said data and information are onlyrecorded within said batch record and said final report; and confirmingthe calibration status of said analytical instrumentation by saidprogram wherein said taking of said data without said confirmation ofproper calibration causes said taken data to be identified as improperdata in both said batch record database and said final report.
 5. In asystem for managing and reporting laboratory data of the type producedat one or more remote data-taking stations in accordance with a set ofpre-existing procedures and formatted into a report, and wherein saidprocedures require the preservation of any data recorded at said remotedata-taking stations, the improvement wherein; said data, once produced,is transmitted instantaneously from each of said one or more remotedata-taking stations to a main data-storing and data-manipulatingstation without being recorded at said one or more remote data-takingstations, to thereby avoid said preservation requirement at said remotedata-taking stations; said main data-storing and data-manipulatingdevice is a computer having a program for combining said pre-existingprocedures with said laboratory data and into a final report, said finalreport describing both said procedures and said laboratory data; saidprogram further produces test instructions from said pre-existingprocedures and said remote data-taking stations receive saidinstructions and produce said laboratory data in accordance therewith;said instructions further include the requirement for the taking ofmeta-data at the remote data-taking stations and said meta-data istransmitted to said computer and said final report further describessaid meta-data; said meta-data further includes remote data-takingstation calibration data and said instructions include the requirementfor the confirmation of proper calibration of said remote data-takingstations and wherein said taking of said data without said confirmationof proper calibration is denied by said program; and said meta-datafurther includes remote data-taking station calibration data and saidinstructions further include the requirement for the confirmation ofproper calibration of said remote data-taking stations wherein saidtaking of said data without said confirmation of proper calibrationcauses said taken data to be identified as improper data by saidprogram.
 6. In a system for managing and reporting laboratory data ofthe type produced at one or more remote data-taking stations inaccordance with a set of pre-existing procedures and formatted into areport, and wherein said procedures require the preservation of any datarecorded at said remote data-taking stations, the improvements wherein;said data, once produced, is transmitted instantaneously from each ofsaid one or more remote data-taking stations to a main data-storing anddata-manipulating station without being recorded at said one or moreremote data-taking stations, to thereby avoid said preservationrequirement at said remote data-taking stations; said data istransferred instantaneously from said each of said one or more remotedata-taking stations to said main data-storing and data-manipulatingstation by wireless communication; said main data-storing anddata-manipulating device is a computer having a program for combiningsaid pre-existing procedures with said laboratory data and into a finalreport, said final report describing both said procedures and saidlaboratory data; said program produces test instructions from saidpre-existing procedures and said remote data-taking stations receivesaid instructions and produce said laboratory data in accordancetherewith; said instructions include the requirement for the taking ofmeta-data at the remote data-taking stations and said meta-data istransmitted to said computer and said final report further describessaid meta-data; and said meta-data further includes remote data-takingstation calibration data and said instructions further include therequirement for the confirmation of proper calibration of said remotedata-taking stations wherein said taking of said data without saidconfirmation of proper calibration causes said taken data to beidentified as improper data by said program.
 7. A method of ensuringreliability in auditable data taken from analytical instruments duringevaluation of medical, pharmaceutical and biological products and storedin a data-recording system wherein each instrument's calibration statusis electronically confirmed by said system before said data takentherefrom is accepted by said system.
 8. The method of claim 7 whereinall of said auditable data taken at said analytical instruments istransferred instantaneously and electronically to a centraldata-recording apparatus, and wherein said auditable data is recordedonly in said central data-recording apparatus.
 9. A method ofelectronically managing measured, calculated and observed data of thetype requested by pre-existing procedures and obtained throughanalytical instrumentation or by observation, said method comprising thesteps of: providing a data manipulating device which contains aninformation management program; loading a single set of instructionscontaining said pre-existing procedures into said data manipulatingdevice, wherein said data manipulating device creates a set ofprocedural instructions; providing said procedural instructions to saidprogram, for use thereby in the generation of a record database of agiven lot of products and a report format; providing said proceduralinstructions to one or both of said analytical instrumentation and anobserver, for use thereby in the taking of one or both of said measuredand observed data and information from which said calculated data isgenerated confirming the calibration status of said analyticalinstrumentation by said program, and wherein said taking of said datawithout said confirmation of proper calibration is denied; retrievingany taken of said measured and observed data into said record database;confirming the eligibility of any individual attempting to modify anysaid previously retrieved data in said record database and wherein witheligibility confirmation modified data is retrieved and said previouslyretrieved data is returned, and without eligibility confirmation saidmodified data is retained; retrieving any taken of said information intosaid program for generation thereof into said calculated data and thenretrieving said calculated data into said record database; combiningsaid one or more of said measured, calculated and observed data fromsaid record database with said report format by said program, to producea final report therefrom; and wherein said data and information are onlyrecorded within said record and said final report.